Connector for Spiral Drain Fr 15-19 - Fittinig device designed to facilitate the - REDAX SPA

Duns Number:338664915

Device Description: Fittinig device designed to facilitate the connection of the tubes/drainage catheters.

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More Product Details

Catalog Number

10527

Brand Name

Connector for Spiral Drain Fr 15-19

Version/Model Number

10527

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

GCD

Product Code Name

Connector, Catheter

Device Record Status

Public Device Record Key

21ccc30c-a9dd-4051-999d-92fb735e5671

Public Version Date

May 19, 2021

Public Version Number

1

DI Record Publish Date

May 11, 2021

Additional Identifiers

Package DI Number

18034139291120

Quantity per Package

50

Contains DI Package

08034139291123

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"REDAX SPA" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 105
2 A medical device with a moderate to high risk that requires special controls. 1